Tamper-resistant assembly for securing valuable material

ABSTRACT

The invention provides a tamper resistant assembly that that securely contains a valuable material. The assembly has a container for holding the valuable material, an optional carrier that contains the container, one or more cover components that enclose the valuable material in the container, and one or more labels having a plurality of devices that reveal tampering by distortion of at least one of the plurality of devices. The label(s) are positioned so that dislodging a cover component causes a detectable distortion in at least one of the plurality of devices, thereby revealing tampering with the assembly. In one embodiment the label can be affixed partially to a surface of a cover component and partially to a surface of the container or the optional carrier. Also disclosed are methods of detecting tampering and method of manufacturing a temper-resistant assembly. Because the assembly allows a remote validator to validate the assembly prior to providing essential instructions or authorization for conducting procedures on valuable material contained by the assembly, the manufacturer is assured that its procedures are being provided only to authorized persons.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under U.S.C. §119(e) to U.S.Provisional Patent Application No. 61/988,045 filed May 2, 2014, theentire contents of which is herein incorporated by reference.

BACKGROUND OF THE INVENTION

Valuable materials include those for which a great deal of time andprecision has been expended for their production. Manufacturers andproviders of such materials have always been desirous a methods ofprotecting those materials and ensuring that they are not vulnerable tocopying, counterfeiting, or unauthorized use. There is therefore acontinuing need for devices and methods for securing such valuablematerials. This need has expanded to include the need for producers toensure that proprietary products manufactured are not tampered with oropened, and therefore subjected to counterfeiting or unauthorized use,after the manufacturing and sale process is complete. Manufacturers havesometimes sought to satisfy at least some of these needs by resorting toparticular designs of tamper evident labels, which typically utilize adetectable pattern or frangible liner that is secured with an adhesiveto thereby prevent tampering and counterfeiting. More robust forms oftamper resistance are described in U.S. Pat. No. 7,098,792, which uses acircuit based sensor sensitive to reveal tampering and US 2001/0035261,which combines a fluorescent taggant with an optically variable image.These devices utilize a visual inspection to reveal tampering. Thisinspection is typically performed by the end user and authorization orvalidation by the producer is not typically available with these methodsand devices. Presently, there are no devices or methods available thatutilize a mated set of components with multiple mechanical and visualfeatures that ensure that authorized products sold have not beentampered with or subject to counterfeiting, and which also allow theproducer to authorize or validate the products at the point of use.

There is therefore a need for an automated way to detect if amanufactured product containing valuable materials has been opened,tampered with or is otherwise counterfeit, which can occur duringtransportation or storage of the manufactured device. There is also aneed for manufacturers to have a method of validating or authorizing theuse of materials that have an origin at a facility under their control.

SUMMARY OF THE INVENTION

The present invention provides a tamper resistant assembly that thatsecurely contains a valuable material. The assembly has a container forholding the valuable material, one or more cover components that enclosethe valuable material in the container, optionally a carrier thatcontains the container, and one or more labels having a plurality ofdevices that reveal tampering by a detectable distortion of at least oneof the plurality of devices. The one or more labels are positioned sothat any attempts to open the container and access the valuable materialcontained inside will cause distortion in one or more of the pluralityof devices or features in the label(s), and such distortion isdetectable by a detection system (e.g. an optical detection system)and/or a remote validator. If such distortion is detected authorizationcan be withheld or the issuance of instructions for performing a methodon the valuable material can be denied by the party controlling theremote validator. Because the assembly allows for a remote validator tovalidate the assembly prior to providing the authorization and/orinstructions for conducting procedures on the material, the manufactureris assured that its materials and procedures are being provided only tovalidly purchased materials and for authorized uses.

In a first aspect the invention provides a tamper resistant assemblythat securely contains a valuable material. The assembly has a containerfor holding the valuable material and, optionally, a carrier comprisingthe container; one or more cover components that enclose(s) the valuablematerial in the container; one or more labels comprising a plurality ofdevices that reveal tampering by distortion of at least one of theplurality of devices, the one or more labels positioned so thatdislodging one or more of the one or more cover components causes thedistortion of at least one of the plurality of devices. The distortionis detectable by a detection system and tampering with the assembly isrevealed. The label can be affixed partially to a surface of a covercomponent, and partially to a surface of the container or to theoptional carrier comprising the container. In various embodiments thedetection system of the assembly can be an optical detection system, andthe distortion can be detectable by a remote validator. The label canhave multiple layers, which can have the plurality of devices. Theplurality of devices can be selected from one or more of: a patterndetectable under light of a first range of wavelengths, a pattern orsubstance detectable under light of a second range of wavelengths, apattern detectable under light of a third range of wavelengths, afrangible layer, a pattern detectable under visible light, a patterndetectable under infra-red light, a taggant ink detectable underultra-violet light, a barcode, a hologram, and an RFID label.

In some embodiments the assembly has a carrier that contains thecontainer and the label is affixed partially to a surface of a covercomponent and partially to a surface of the carrier comprising thecontainer. The label can have a device detectable under visible light, adevice detectable under infra-red light, and a device detectable underultra-violet light when the label is distorted. The label can have afrangible layer that is distorted upon application of shear forces andalso have a pattern detectable in visible light present on the frangiblelayer. The distortion can be distortion of the pattern detectable undervisible light.

The label can have a layer that has a pattern that is detectable underinfra-red light, and/or a taggant ink that is detectable underultra-violet light when the label is distorted to expose the taggant inkbut is not detectable when the label is intact. In some embodiments thelabel has a first layer that with a pattern detectable under visiblelight and a second layer with a pattern detectable under infra-redlight, and the second layer is present on top of the first layer.

In some embodiments the container of the assembly is a multi-well plate.One or more of the cover component(s) can seal the valuable material inthe container, and the valuable material can be fragments of nucleicacid that, when joined in a particular order, comprise a larger desiredsequence of nucleic acid. The fragments of nucleic acid can be randomlyplaced in a plurality of individual compartments or wells of thecontainer. In another embodiment the valuable material is situated inindividual compartments or wells of the container and one or more of thewells also has one or more taggant inks.

In another aspect the invention provides a method of detecting theoccurrence of tampering with an assembly containing a valuable material.The method involves analyzing assembly of the invention as describedherein with a detection system, and detecting the presence or absence ofdistortion in one or more of the plurality of devices and therebydetecting whether tampering with the assembly has occurred. Thedetection of the distortion can be communicated to a remote validator,which can be a computer that receives information about the detection ofdistortion in one or more of the plurality of devices, or informationabout the absence of distortion in the plurality of devices. The methodscan also involve a step of removing one or more cover components anddetecting the presence or absence of one or more taggant inks detectableat a specific wavelength or range of wavelengths in one or more of theindividual compartments or wells.

In another aspect the invention provides a method of manufacturing atamper resistant assembly that securely contains a valuable material.The method involves placing the valuable material in a container thatis, optionally, comprised by a carrier; placing one or more covercomponents on the container; positioning one or more labels of theinvention as described herein so that dislodging at least one covercomponent causes distortion in at least one label, the distortiondetectable by a detection system as described herein. The positioningcan involve affixing the one or more labels partially to a surface ofthe one or more cover components and partially to a surface of thecontainer or the optional carrier that comprises the container. Themethods also can involve placing one or more taggank inks detectable ata specific wavelength or range of wavelengths in one or more individualcompartments of the container.

These and other objects, aspects, and features of the invention willbecome more fully apparent to those of ordinary skill in the art uponreview of the following detailed description of the invention and theclaims in conjunction with the accompanying figures.

DESCRIPTION OF THE DRAWINGS

FIG. 1 provides an exploded view of a tamper resistant assembly of theinvention. This embodiment has a carrier and two cover components 105.

FIG. 2 provides an exploded view of a label of the invention.

FIG. 3 provides an exploded view of a tamper resistant assembly of theinvention. This embodiment has a carrier and latches that are used tosecure the cover component(s) to the carrier. The container is containedin the carrier.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides distinct advantages over existingtechnology for securing valuable materials and ensuring that they arenot tampered with or counterfeited. The invention allows a producer ofvaluable materials to validate or authorize the materials prior toactivity at the point of use. The invention is also useful in anyapplication where the origin of materials must be verified. Theinvention provides an assembly for containing a valuable material thatutilizes a design and a label having multiple devices that revealtampering by distortion of at least one of the devices in the label.With such an assembly one is able to achieve a highly increased level ofsecurity for a valuable product. In a particular embodiment it was foundthat by specifically ordering the devices within the label, one is ableto incorporate a maximum number of devices and a resulting increase insecurity.

FIG. 1 provides an exploded diagram of an embodiment of an assembly ofthe invention, showing its component parts. In this embodiment theassembly has a separate carrier, but in other embodiments the carriercan be combined with the container into a single component, oreliminated entirely. The container 101 is situated securely within thecarrier component 120.

The container 101 has one or more cover components 105, which aresecured on the container. The cover or cover components can have severalpurposes. In various examples the cover or cover components is/are thatpart of the assembly that prevents access to the materials in thecontainer without first removing or dislodging one or more covercomponents and thereby cause a distortion in at least one of theplurality of devices in the one or more labels. The cover or covercomponents can also serve to protect the materials in the container. Theassembly can have one or more cover components that comprise the cover.While FIG. 1 depicts the cover 105 as having two components (a coverpiece 105 a and a sealing pad 105 b), in different embodiments the coverhas one or two or three or more than three components as desired for thespecific application. In various embodiments the cover components 105can include a cover piece 105 a, one or more sealing pads 105 b, layers,or membranes (e.g., a foil sealing cover) that seal the materials withinthe container and prevent them from drying out or otherwise being lostor adulterated, and can also serve as a protective layer for thecontainer. Other cover components (not shown) can be included inadditional embodiments, and some cover components can be eliminated,depending on the convenience of the application. The cover piece 105 a,sealing pad 105 b, thermally conductive pad 105 c (shown in FIG. 3),adhesive film 105 d (shown in FIG. 3), layers, or membranes, whenpresent as one or more separate components, are considered as componentsthat together comprise the cover 105. Thus, in various embodiments thelabel can be affixed partially to a surface of the container andpartially to a surface of any one or more cover components that may bepresent in the embodiment, e.g. partially to the surface of thecontainer and partially to a surface of a sealing pad; or partially tothe surface of the container and partially to a surface of a sealinglayer; or partially to the surface of the container and partially to asurface of a sealing membrane, or partially to a cover piece andpartially to the container and/or carrier. In each case it is consideredas being partially affixed to the cover because the cover includes anyof the cover components, as the term is used herein. In anotherembodiment of the assembly the label is not affixed to the container butinstead is affixed partially to two or more components of the cover,i.e. partially to at least two of any of the cover piece, sealing pad,sealing layer, sealing membrane, or whatever other cover component maybe included in the embodiment. The one or more cover components enclosethe valuable material in the container and while it is desirable that atleast one component of the cover actually seal the valuable materials inthe container, this is not a requirement, but it is desirable that atleast one component of the cover substantially seal or protect thevaluable materials in the container. By enclosing the valuable materialis meant that the valuable material does not escape the container evenupon inversion of the container and/or assembly. In yet anotherembodiment the label is affixed to any one or two or more components ofthe assembly in a manner so that the valuable materials in the containercannot be accessed without causing a distortion of at least one of theplurality of devices in at least one label.

In still another embodiment the labels are positioned so that dislodgingone or more cover component(s) causes a distortion to occur in at leastone of the plurality of devices in the label(s). In a particularembodiment one or more labels are affixed to separate surfaces of thecontainer and/or carrier. In these embodiments the label(s) envelop oneor more cover components of the assembly so that the one or more covercomponents cannot be removed from the assembly and/or materials in thecontainer cannot be accessed without causing distortion in at least oneof the plurality of devices in the label. In some of these embodimentsthe labels are not affixed to a cover component but rather to twoseparate areas of the container or two areas of the carrier or at leastone area of the container and at least one area of the carrier, or totwo areas of the cover, and can envelop or wrap around the containerand/or one or more cover components. In still other embodiments two ormore areas of the label are affixed to each other so that the labelenvelops the assembly partially or completely (e.g. in the shape of aloop), thus rendering it impossible to dislodge the one or more covercomponents without causing a distortion in the label. The assembly canthen be shaped so that the one or more cover components cannot bedislodged and access to the valuable materials gained without causing adistortion in at least one layer of at least one label. By dislodge ismeant movement of a cover component so that access is gained to thevaluable materials inside the container.

When more than one cover component (e.g., sealing pad, layer, ormembrane) is present they can also serve a reinforcing function. In someembodiments the cover includes a sealing cover or sealing pad made offoil or another suitable material, and no plastic or metal or other partneed be present to form the cover. In FIG. 1 there are also depictedlabels 115 (4 shown), which are shown as being partially affixed to acover piece 105 a. Another portion of the labels 115 can be affixed to asurface of the container or another cover component or the carrier (whenpresent) when the assembly is assembled, so that none of the labels 115can be removed, and thus allow the cover to be removed or dislodged andaccess gained to the materials inside the container without causing adistortion in one or more of the devices in one or more of the labels115. There is no limit to the shape or number of labels that can beprovided with the assembly as the invention accommodates a wide varietyof shapes and numbers of labels, and the number of labels is at leastone. The cover components of the container can be made of any suitablematerial, e.g. plastic or metal. In different embodiments the cover canalso be connected to the container or to a carrier (when present), or toboth. In different embodiments the cover can be movable about a hinge,or can partially or completely slide off the container to provide accessto the valuable materials. When the cover is a foil seal, it can besimply peeled back when the container is ready for use and can bevalidated or authorized before or after such peeling.

In another embodiment one or more cover components can have one or morelatches 301 or holding mechanisms that lock or snap the cover onto thecontainer, as depicted in FIG. 3. The embodiment depicted in FIG. 3 hasa carrier 120 or lower capture frame and a container 101 and there aredepicted three cover components 105, but it is understood the assemblycan have one or two or three or more than three cover components. Inthese embodiments cover component 105 c is a thermally conductive pad,cover component 105 d is an acrylic adhesive film, and cover component105 a is a stamped aluminum cover piece. Other cover components can beincluded and the cover components can be made of any suitable materialfor the purpose of the component such as, for example, foil or plasticor metals. Component 301 a is a portion of a latch, which fits snuglyinto latch portion 301 b, which is present on the carrier. Duringmanufacturing and after the assembly has been assembled one or more ofthe label(s) can be situated on or over the latch, thus preventing thecover component 105 a from being removed without causing distortion ofat least one of the plurality of devices present in one or more layersof the label. In one embodiment the latches 301 can be disengaged by akey on an instrument that has previously performed the detection of theoccurrence of tampering with the assembly.

Container

The containers utilized in the assemblies of the invention can be anycontainer that can hold a valuable material. In particular embodimentsthe container is a biological plate or multi-well plate (e.g. amulti-well or 96 well plate) containing DNA or another material forbiological applications. But in other applications the containers canhave any internal volume and any number of individual compartments orwells of appropriate volume for the application is useful. Examples ofadditional valuable materials include, but are not limited to, aminoacids, peptides, proteins, RNA, or a reagent or mixture of reagents forconducting a procedure, method, or assay. But any valuable material,whether biological or inorganic, can be contained in the container.

Carrier

The carrier is an optional component, which can provide a secure seat orholder for the container and to allow the cover to be placed on top ofthe container so that one or more labels can be affixed to preventaccess to the valuable materials without causing distortion in at leastone of the plurality of devices in the label(s) (e.g., partially to acover component and partially to a surface of the container or to acarrier containing the container). In some embodiments the carrier andcontainer can be comprised as a single component or unit. In otherembodiments the carrier can be a separate component from the containerand can take the form of plastic or other suitable material, into whichthe container fits securely or is otherwise held, and that allows forthe cover to be placed on the container. The carrier can be designed sothat it interacts with the cover piece or another cover component andprovides a convenient location for one or more of the labels to bepositioned. The carrier can also be sized and shaped to allow theassembly to fit securely and conveniently onto an instrument thatperforms validation or authorization or otherwise performs a procedureon the valuable materials in the container. In some embodiments thecover and carrier can also be comprised as a single unit or all of thecover, carrier and container can be comprised as a single unit made ofany suitable material. The precise form or arrangement of thesecomponents is not critical, and any configuration or form of componentsallowing for these purposes will be suitable in the invention.

Label

The label can be positioned so that dislodging one or more of the covercomponents causes a distortion to occur in at least one of the pluralityof devices in the label(s). In some embodiments the label is affixed toone or more components of the assembly so that the valuable material inthe container cannot be accessed without causing distortion in at leastone of the plurality of devices in a label. “Access” refers to theability to manipulate materials in the container, or remove materialsfrom, or add materials to the container. In some embodiments the labelis affixed partially to a surface of a cover component and partially toa surface of the container or a carrier comprising the container, sothat the label cannot be removed without causing distortion in at leastone of the devices in the label. The label contains one or more layersor plies having at least one device that becomes distorted in adetectable way if the assembly is tampered with, for example byattempting to remove or manipulate the label and gain access to thematerial in the container. In some embodiments each layer of the labelhas a device and will serve a different purpose and the various layerswill combine to fulfill the objectives of the label of the invention.While is it desirable for the label(s) to have a plurality ofincorporated devices in some embodiments the label(s) can have a singledevice as described herein. In some embodiments the assembly can utilizemultiple labels, each having one or more of the devices that revealtampering, as described herein. In one embodiment the assembly hasmultiple labels and the labels can comprise a different type of devicedescribed herein.

In various embodiments the label has one layer or multiple layers.Examples of layers include, but are not limited to, one or more of 1) alayer that has frangible properties, e.g., a layer that has a web ofsemi-elastic thermoplastic or that has a metallic foil or that hasflexible tabs built into the layer; 2) a layer printed with a taggantink that is detectable under light of one or more first specificwavelength(s) or range(s) of wavelengths (e.g., of the uv spectrum); 3)a layer that has a pattern that is detectable under light of one or moresecond specific wavelength(s) or range(s) of wavelengths (e.g., thevisible spectrum); and/or 4) a pattern that is detectable under light ofone or more third specific wavelength(s) or range(s) of wavelengths(e.g., infra-red spectrum). A pattern detectable under light of onewavelength or range of wavelengths (e.g., the visible spectrum) can bepresent in a layer on or near the upper surface of the label, and apattern detectable under light of another wavelength or range ofwavelengths (e.g., infra-red spectrum) can be printed on the oppositeside of the same layer, or on another layer. The label can also have atensioned layer that covers all or a part of a layer having a taggantink. In addition to these layers the label can have one or more adhesivelayers in between and/or above and/or below these layers for the purposeof assembling the label and/or providing a layer to adhere to one ormore cover components, container, or carrier. In certain embodiments thebottom of the label is that side affixed to the container and carrier orcover, and the top of the label can be considered the opposite side ofthe label. The label can also contain a top layer which can be atransparent layer that protects the label and covers the label.Therefore not every layer of the label must contain a device thatreveals tampering. In other embodiments the label can have additionallayers, for example layers with printing detectable at a fourthwavelength or range(s) of wavelength(s)) or can have some combination ofthese layers. Any of the layers and any combination of the layers can becomprised in the label. In the invention the taggant ink is notnecessarily one that is detectable under ultra-violet light and otherappropriate taggant inks can also be used in the invention.

The cutting of the label can be used to add a further layer of securityto the method of detecting tampering. The label can be cut by acomponent of the instrument that performs the validation, or by aseparate instrument, or even by hand. The label can be sized and shapedso that the force of the cutting instrument is directed towards aspecific area of the label to ensure a cut that exposes a taggant inkpresent at one layer of the label. As the label is cut the taggant inkbecomes exposed to the detector, and the ability to detect the presenceof the taggant ink is therefore further confirmation that the assemblyis valid (i.e. its source is an authorized, legally appropriateprovider). Authorization refers to the acknowledgment by a legallyappropriate provider (either directly or through one or more thirdparties) that an assembly is valid.

Plurality of Devices

The label(s) can contain one device or a plurality of devices that wouldreveal if tampering with the assembly had occurred. A number of devicescan be provided in the label for this purpose, and a label can have oneor more of these devices incorporated within each layer of the label.Examples include, but are not limited to a frangible layer, a patterndetectable under light of one or more first wavelength(s) or range(s) ofwavelengths (e.g., visible light), a taggant ink detectable under lightof one or more second wavelength(s) or range of wavelengths (e.g.,ultra-violet light), a pattern detectable under light of one or morethird wavelength(s) or range of wavelengths (e.g., infra-red light), abarcode, a hologram, and an RFID label. Other types of devices that canbe incorporated into the label will also be realized. In someembodiments more than one device can be incorporated into the same layerof the label. The label can also have layers that are simply adhesivelayers. These layers may therefore not have any device but rather arepresent to form adhesive layers for adhering the layers to one anotheror to the container and/or cover and/or carrier. The labels are notlimited to any particular number of layers and any number of layers orpatterns can be used, which can be detectable under any convenientnumber of types or wavelengths of light. Any suitable one or morewavelength(s) or range(s) of wavelengths of light can be used. Indifferent examples the ranges of wavelengths include from about 390 toabout 700 nm, or from about 450 to about 650 nm; or less than 400 nm orfrom about 10 nm to about 400 nm or from about 100 nm to about 350 nm;or from about 700 nm to about 1 mm or from about 750 to about 950 nm orgreater than 700 nm.

The frangible layer of the label is designed to be easily distorted orfragmented when subjected to mechanical stress or shear forces. It canbe made of a material that fragments or otherwise becomes irreversiblychanged in a detectable manner after being subjected to mechanicalstress and cannot resume its prior configuration. Examples of materialsthat can be used for this layer of the label include, but are notlimited to, biaxially oriented polypropylene, PET, lacquered paper, PVC,latex, rubber, thermoplastic urethane, or a material with a thin waxlayer. But the person of ordinary skill with resort to this disclosurewill realize a number of other frangible materials that will find use inthe invention. This can also be a tensioned layer and can be a stretchedmaterial so that distortion in this layer results in a detectable lossof the configuration of the layer and tampering is revealed.

A layer of the label can serve to cover all or part of a lower layerthat is printed with one or more taggant inks (detectable under uvlight) and therefore render all or part of the taggant ink(s) unable tobe detected because of the covering layer. This covering layer can be atensioned layer, e.g. a web of semi-elastic thermoplastic that istensioned prior to lamination. It can also be a layer of metallic foil(e.g. aluminum), or web that is cut in a particular pattern to create aseries of flexible tabs. Upon being subject to distortion the layercontracts due to release of the tension, thus becoming smaller andexposing the taggant ink below it.

Another layer of the label can be made of a material that will have apattern on the surface that is detectable under visible light, forexample by an optical detector. The pattern can be a printed pattern.This layer can also be made of an opaque or a semi-opaque material. Insome embodiments this layer can also have printed on the underside oropposite side of the layer a pattern detectable under light of infra-redwavelengths, but the patterns detectable under visible and infra-redlight can also be present on different layers. The patterns detectableunder the visible and IR wavelengths can each be any detectable patternsuch as, for example, a cross-hatched pattern or another discernibleshape. But any detectable pattern can be used. The layer containing thepattern detectable under visible light can also be the frangible layer,and thus more than one device can be present in a single layer of thelabel.

Another layer of the label can contain one or more taggant ink(s). Thetaggant ink(s) can be detectable under light of one or more uvwavelengths or range(s) of uv wavelengths, for example by an opticaldetection system. The layer can be arranged so that all or part of thetaggant ink(s) is/are not visible as long as there is a layer coveringthe taggant ink (e.g. a tensioned layer). In some embodiments a taggantink can be present that has a first detectable pattern when a tensionedlayer is intact and a second pattern when the tensioned layer has beendistorted. The second pattern can be simply a detectable change in thefirst pattern. In other embodiments one taggant ink can be detectablewhen the tensioned layer is intact and a second taggant ink detectablewhen the tensioned layer has been subjected to distortion. In oneembodiment the taggant ink(s) can be printed on the underside of thecovering layer, or can be a separate layer. But if the covering layer ofthe label is distorted the area of printed taggant ink is exposed orchanged and such exposure or change becomes detectable under light of uvwavelengths.

The taggant ink can add important identifying characteristics to theassembly. For example in some embodiments the taggant ink can emit lightat one or more emission wavelengths or ranges of wavelengths whenilluminated by light of one or more excitation wavelengths or ranges ofwavelengths. Particular wavelengths or ranges of wavelengths of the inkcan be known to the manufacturer of the assembly and associated with theparticular assembly. Thus in those embodiments where validation orauthorization is to be communicated by a remote validator, the opticaldetection system of the user can communicate to the remote validator thewavelengths being emitted by the taggant ink. If these emittedwavelengths correspond to those known to be contained in the taggant inkof that assembly by the manufacturer, this is an indication of thepresence of a valid assembly. In some embodiments the taggant ink canalso have one or more RFID tags detectable at particular wavelength(s),which can also have identifying characteristics useful for this purpose.The identity of the assembly, for example lot number, can be easilyascertained by including on the assembly a barcode or other identifyingnumber or device that is detectable by the instrument in a manner thatcan be read by the instrument. This information can also be transmittedto the remote validator and therefore the remote validator can correlatethe specific wavelengths of light emitted from the device beingvalidated with that information known about the device from theidentification device. The remote validator therefore has further meansto validate the assembly.

There can also be present a layer that is transparent and covers andprotects all the other layers of the label, and assists adherence of thelabel to the assembly or to itself. In some embodiments this is the toplayer of the label. In one embodiment the label of the inventiontherefore uses both mechanical and visual features to ensure labelintegrity and detect the presence or absence of tampering. A mechanicalfeature is one that is based on a physical change in the label.

An embodiment of a label of the invention is depicted in exploded viewin FIG. 2. Layer 200 shows an adhesive layer for adhering the label to asurface of the cover and container and/or carrier. On top of layer 200is layer 205, which is a frangible layer that also has a pattern that isdetectable under light of a first wavelength or range of wavelengths(e.g., visible light) present on its surface. Layer 210 has an areahaving a taggant ink thereon that is detectable under light of a second(emission) wavelength or range of wavelengths (e.g., ultra-violetlight). In this embodiment the taggant ink is printed on the layer.Layer 210 is covered by tensioned layer 220 so that when the label isintact taggant ink of layer 210 is not visible under light of excitationwavelength. If the label is distorted, which is very easily done undermechanical stress, then layer 210 becomes exposed and the ink willbecome detectable under the light of the second wavelength or range ofwavelengths (e.g., ultra-violet light) by the detection system. Layers215 are adhesive layers present for the purpose of holding the variouslayers together. Additional adhesive layers can also be present as partof the label (not all shown). Layer 220 covering layer 210 is a web ofsemi-elastic thermoplastic that is tensioned prior to lamination, or inother embodiments is a layer of metallic foil (e.g. aluminum or asimilar metal) but in other embodiments (not shown) it can be cut in ashape to form tabs that cover a layer beneath it having the taggant ink.Layer 225 is a transparent layer that has a pattern printed on itsunderside that is detectable under light of a third wavelength or rangeof wavelengths (e.g., infra-red light). This layer ensures that acounterfeit layer cannot be placed over the label to mimic the patterndetectable under the light of the first wavelength or range ofwavelengths (e.g., visible light) and thereby gain an unauthorizedvalidation or authorization of the assembly, for example by a remotevalidator.

Inspection/Authorization Process and Use

The process utilized to inspect the label and gain validation orauthorization, for example from a remote validator, can be varied.Validation refers to a process by which a clearance or authorization isobtained, which can allow the instrument to proceed with method steps.The method steps can be instructions or steps for performing anoperation on the material within the assembly such as, for example, theassembly of a DNA molecule or performance of an assay or otherbiological procedure. The instructions can be software for performing anoperation on the valuable material in the assembly, which instructionscan be present as data within the instrument itself and accessed uponreceipt of an authorization code, but in other embodiments theinstructions are downloaded from the remote validator or a computerunder the control of the remote validator. The remote validator is acomputer or other electronic device that receives information from theinstrument (directly or indirectly) seeking clearance or authorizationand, after confirming that the assembly is a valid assembly communicatesauthorization (or the completion of validation) to the instrument,either directly or indirectly. The remote validator is not necessarilyentirely electronic. It can also be under the control of a person thatevaluates information communicated from the instrument (directly orindirectly) and it can be the person that takes an action communicatingthe authorization. The remote validator can receive validationinformation from the instrument seeking validation and analyze thatinformation to determine whether or not authorization should occur.Validation information includes all information relating to the identityof the assembly and whether or not tampering with the assembly hasoccurred. In other embodiments validation and authorization is performedby the instrument seeking validation. In these embodiments theinformation necessary to validate the assembly is present within theinstrument seeking validation or within a second instrument connected tothe instrument seeking validation. The instrument seeking validation istherefore able to access information required to establish validation,whether through the internet to a remote validator or computer under thecontrol of a remote validator, or whether to an instrument otherwiseconnected to the instrument seeking validation, or whether suchinformation is contained within the instrument itself. If validation isachieved, it can similarly access information necessary to perform theappropriate operation on the valuable material in the container.

As an example, the process can involve placing the assembly incommunication with an instrument that will validate the assembly and, insome embodiments, can also perform steps of accessing the material andperforming appropriate method steps on the material. But the instrumentcan also be one that simply gathers validation information about theassembly. In a particular embodiment the instrument is a robotic gantrythat performs a method using the valuable material within the assembly.In a particular embodiment the valuable material is a plurality of DNAmolecules located in multiple wells of the container and the method is aseries of steps for assembling a larger DNA molecule.

The method of validating and authorizing can involve different stepsthat confirm that no distortion has occurred in any of the plurality ofdevices contained in the label(s), and thereby detect the absence oftampering. Some or all of the steps can be performed by a detectionsystem, for example an optical detection system. The process can containsteps of 1) activating light of one or more first (visible)wavelength(s) and determining the absence of distortion in a frangiblelayer of the label that has a specialized printed pattern—an absence ofdistortion in this layer of the label is taken to indicate that therehas been no attempt to, for example, peel back the label and gain accessto the valuable materials within the container (e.g., to remove orreplace them); 2) activation of light of one or more secondwavelength(s) (e.g., uv) to reveal an absence of detection of thepresence of taggant ink—an absence of distortion or detection in thislayer is taken to indicate that the covering layer is intact (referringto an absence of detectable distortion) and there has been no attempt toremove the layer covering the layer with the taggant ink; 3) activationof a light of one or more third (e.g., infra-red) wavelength(s) isperformed to detect a pattern printed on the underside of a layer, whichpattern is detectable under light of infra-red wavelength. An absence ofdistortion in this layer is taken to indicate that this layer has notbeen peeled off or removed and replaced with a counterfeit layer havingthe pattern detectable under visible light. Additional steps can beperformed on additional layers that can be included in the label(s)until the necessary level of security has been met. These steps can beperformed in any order. These steps can be performed by the sameinstrument that removes the cover and/or performs operations on thevaluable materials inside the container, or by a separate instrument.The operations performed will depend on the nature of the valuablematerial and the purposes to which the invention is applied. In oneembodiment the valuable material is a plurality of DNA molecules and theoperations are steps for joining the plurality of DNA molecules tosynthesize a larger DNA molecule.

The instrument performing the validation can do so in an automatedfashion. The instrument can have various components for performingvarious steps. It can have a detection system, for example an opticaldetection system with the required hardware and software to performnecessary illuminations and detections of reflected wavelengths andpatterns of light. In various embodiments the instrument can havecomponents for performing the validation and authorization processes,but can also have components for receiving software instructions from anelectronic device under the control of the remote validator, and canalso have components for performing a series of operations on thematerial in the container, e.g. reactions for the joining of pieces ofDNA.

In some embodiments the instrument performs steps of gatheringvalidation information as described herein and transmits that validationinformation to a remote validator. The remote validator then analyzesthe information and communicates validation or authorization (or theabsence thereof) to the instrument, e.g. via the internet or otherelectronic communication. There can be one or more other instruments, oreven persons, in between the instrument and the remote validator. Inembodiments where the instrument performs steps on the material insidethe container, a result of validation can mean the instrument is enabledto access programming for proceeding to perform said steps, for exampleby receiving an authorization code that unlocks the software. In someembodiments the programming steps for the operation can be downloadedfrom the remote validator or a computer under the control of the remotevalidator upon a result of validation or authorization. Conversely, aresult of no validation or authorization will mean that the instrumentis not enabled to access the programming for performing said steps, orthat the remote validator does not allow a download of programming.Therefore, the steps can be performed only when a validated assembly isbeing used to perform the steps and authorization has been obtained bythe instrument.

A detection system is any system, or electronic, or mechanicalinstrument that is able to detect distortion in one or more layers ofthe label. In one embodiment the detection system is an opticaldetection system. An optical detection system refers to various types ofoptical detectors that can find use in the invention in detectingdistortion in one or more layers of the label. Such optical detectionsystems are known in the art and include, but are not limited to,photosensors or photodetectors that sense light or other electromagneticenergy. The system can therefore have a pattern recognition capabilityfor recognizing patterns in the label(s) and detecting distortions inthe label(s), for example by applying pattern recognition algorithms.The optical detection system can be of various types. Examples include(but are not limited to) an image sensor, such as those commonly used insmall cameras, or a cryogenic detector that can measure emission ofinfrared photons, or an LED, or an optical detector that can detectphotons, or a photoresistor, or a quantum dot photoconductor orphotodiode, which detect wavelengths in the visible and infra-redwavelengths, a photodiode or photocathode that can detect light in theUV spectrum, or a photomultiplier device. Optical detection systemsuseful in the invention can involve the use of one or more variouswavelengths of light illumination in conjunction with detection and/or avariety of image detection algorithms.

Tampering or Distortion

The label of the invention allows for the detection of the occurrence oftampering with the assembly. Tampering includes, but is not limited to,an attempt to remove all or part of a label and/or to dislodge a covercomponent from the assembly. The assembly is designed so that tamperingwill result in a detectable distortion of at least one layer of thelabel. Distortion refers to the result that one or more layers of thelabel is changed due to applied force, rather than retaining itscohesion as a single object. Distortion can be manifested as afracturing or breaking or loss of material integrity of one or morelayers of the label. Distortion can also include an absence of orfailure of the detector to detect the presence of a device in a layer,and can also be the detection of a substance in or on the label, or alayer of the label (e.g., a taggant ink) that will be detectable iftampering has occurred. As an example distortion can be caused by anattempt to remove the label, such as by peeling or scraping it off orotherwise physically manipulating the label. The multiple layers of thelabel are designed to indicate such distortion in different ways, and toreveal distortion caused by different methods of tampering. Thedistortion is detectable by a detection system, such as an opticaldetection system. Other types of detection systems can also be utilizedin the invention. The type of detection system utilized will depend onthe plurality of devices incorporated into the label.

In some embodiments the valuable material can be fragments of DNA that,when joined in a particular order, make a larger desired sequence ofDNA. This therefore exposes a potential that the fragments of DNA couldbe used to create a prohibited sequence of DNA, such as those that mightbe useable as instruments of bioterrorism. Therefore, in one embodimentthe fragments of DNA comprised in the wells of the container can beplaced randomly into the wells, meaning in an order that is unrelated tothe order in which the fragments are to be assembled. The fragments canalso be placed blindly into the wells of the container, meaning that theidentity of a particular fragment in a particular well is unknown to theend user. In this embodiment the sequence of the fragments and/or theorder of the fragments necessary to assemble the fragments into thelarger desired sequence of DNA is known only to the party controllingthe remote validator. The identity of a fragment and order of assemblyis therefore contained in the software for performing the operation onthe DNA or other valuable material. If, after performing the validationexercise, no tampering is detected and authorization is achieved, theprogramming steps for the series of steps for joining the DNA fragmentscan be downloaded as described herein. Since the sequence present in thespecific wells of the container are not known to the party performingthe DNA assembly reaction, the DNA fragments could not be used in aneffort to utilize the DNA fragments to assemble a prohibited sequence.

In some embodiments one or more taggant inks can be included within oneor more of the wells of the container. As part of validating an assemblythere can be included steps of removing the one or more cover componentsand detecting the presence or absence of one or more taggant inksdetectable at a specific wavelength in one or more of the individualcompartments. As part of a method of manufacturing a tamper resistantassembly of the invention there can be included a step of placing withinthe one or more individual compartments of the container one or moretaggant inks detectable at a specific wavelength. In these embodimentsthe taggant inks can be any as described herein.

The assemblies of the invention can therefore have a combination oftaggant inks present within some of the wells or individual compartmentsof a container. As part of the validation the instrument can illuminatecertain wells of the container with light of one or more specificwavelength(s) or range of wavelengths and detect emitted light at one ormore specific emission wavelength(s) or range of wavelengths. Theexcitation and emission wavelengths used can correlate to the taggantinks known to be present in specific compartments. The particularexcitation and emission wavelengths to be utilized by the instrumentperforming the validation and which individual compartments to beinterrogated can be determined by the instrument from the barcode orother identifying number present on the assembly, as described herein,or can be downloaded from the remote validator. The response from theinterrogation by illumination of the indicated individual compartmentscan then be transmitted to the remote validator as validationinformation and be considered as part of the validation procedure.

Example 1—Validation of an Assembly

In this Example the valuable material in the container is fragments ofDNA that are to be assembled into a larger piece of DNA. The instrumentin this Example has an optical detection system that gathers validationinformation about the assembly. After communicating the information to aremote validator and gaining authorization the instrument downloadssoftware containing a series of operations that the instrument willperform on the pieces of DNA present in the container of the assembly.The operations are instructions for performing a series of reactions forjoining the pieces of DNA.

The assembly is placed in an indicated location on the instrument andthe instrument is activated. Using the optical detection system theinstrument performs the necessary steps of detection using threedifferent types of illumination, which will reveal tampering (or theabsence thereof) indicated by at least three of the layers of the label.This validation can be performed in stages, with each stage involvingactivation of a particular wavelength of light, e.g., UV, IR or visiblelight. This illumination protocol is performed with a label having threeprint patterns that are used to identify and validate it when thefollowing steps are performed. This embodiment uses a label depicted inFIG. 2 described herein and the assembly has four such labels positionedso that each of the four is partially affixed to the cover piece andpartially affixed to the carrier, which fits snugly into the containerand thereby contains the pieces of DNA present in the wells of thecontainer.

The first type of light that is activated is a light of visible (orbroad spectrum) wavelength, which can be used to ensure that eachsecurity label has not been peeled up or removed and placed back intoposition. In this embodiment validation involves utilizing a combinationof micro-perforations to form the frangible layer and specialized printpatterns placed upon the same layer of the label (e.g., FIG. 2, 205).Any attempt to peel back the label will cause the layer to deflagrateinto a number of different pieces, which will cause a distortion in thelayer and in the pattern detectable under visible light. Such distortionwould be detected by the optical detection system and would thus preventvalidation of the assembly. Using illumination with light in the visiblespectrum the pattern is detected as intact.

The optical detection system then proceeds and activates a light thatilluminates the label with light of a second (uv) wavelength. The labelis illuminated at the excitation wavelengths and detection performed atthe emission wavelength. This detects any type of image that might occurin the area of the layer having ultra-violet taggant ink (210) thatemits light of a particular emission wavelength when illuminated withlight of appropriate excitation wavelength. Upon inspection this layeris found to not emit light at the emission wavelength, indicating thatthis layer of the label is also intact. If light is detected at theemission wavelength, this would be taken as an indication thatdistortion of the label has occurred causing the taggant ink to bedetectable, and thus that tampering has occurred. But taggant ink is notdetected.

The optical detection system proceeds and activates a light thatilluminates the label with light of a third (infrared) wavelength, thusrevealing the pattern detectable on the underside of layer 225 underlight of infra-red wavelength. This ensures that a counterfeit layerprinted with a pattern detectable under the light of the first (e.g.,visible) wavelength as in layer 205 cannot be affixed on top of thelabel to camouflage any tampering that may have occurred. An attempt toapply such counterfeit layer would obscure the pattern present on theunderside of layer 225 and result in a denial of validation of theassembly. The IR image is detected, which is taken as an indication thatno tampering has occurred.

In this embodiment the identity of the assembly is determined from abarcode on the assembly and communicated to the remote validator. Theremote validator accesses information to ascertain the wavelengths oflight that should be detectable for that particular assembly under arange of excitation wavelengths. The instrument now proceeds to cut thelabel, which is performed by a component of the instrument and is donein an automated fashion. After cutting of the label the taggant ink isexposed to the optical detection system. The optical detection systemthen illuminates the label with light of a plurality of excitationwavelengths and detects light at a plurality of emission wavelengths. Ifno light is detected at one or more of the emission wavelengths this istaken as an indication that the assembly is counterfeit or has beentampered with because after cutting the label the taggant ink should beexposed and detectable. But light is detected at each expected emissionwavelength, and this is taken as an indication that the assembly and hasnot been tampered with.

Since the above steps do not detect tampering or distortion of any layerof the label, the instrument communicates that information to the remotevalidator with the validation information about the assembly. The remotevalidator is a computer present at an installation under the control ofthe authorized provider of the assembly device. The remote computer ofthe authorized provider then processes the information and determinesthat the assembly is valid. It then communicates authorization to theinstrument performing the validation exercise and the method thatutilizes the valuable material contained in the assembly can proceed.The authorization can be communicated directly by the computer of theauthorized provider, or can be communicated to another computer ordevice that provides the final validation and/or authorization. Thecomputer of the authorized provider can also be programmed to transmitthe instructions for performing a series of steps that utilize thevaluable material, which in this embodiment includes instructions forperforming a series of joining reactions on the pieces of DNA in theassembly.

The invention claimed is:
 1. A tamper resistant assembly that securelycontains a valuable material comprising: a) a container for holding thevaluable material and, optionally, a carrier comprising the container;b) one or more cover components that enclose(s) the valuable material inthe container; c) one or more labels, each comprising a plurality ofdevices that comprise a frangible layer, a pattern detectable undervisible light, and a pattern detectable under infra-red light, thatreveal tampering by distortion of at least one of the plurality ofdevices, d) the one or more labels positioned so that dislodging one ormore of the cover components causes the distortion of at least one ofthe plurality of devices, the distortion detectable by a detectionsystem and thereby revealing tampering with the assembly.
 2. The tamperresistant assembly of claim 1 wherein the label is affixed partially toa surface of a cover component, and partially to a surface of thecontainer or to the optional carrier comprising the container.
 3. Theassembly of claim 1 wherein the detection system is an optical detectionsystem.
 4. The assembly of claim 1 wherein the distortion is detectableby a remote validator.
 5. The assembly of claim 1 wherein the labelcomprises multiple layers which comprise the plurality of devices. 6.The assembly of claim 5 wherein the plurality of devices furthercomprise a taggant ink detectable under ultra-violet light.
 7. Theassembly of claim 2 wherein the assembly comprises a carrier thatcontains the container and the label is affixed partially to a surfaceof a cover component and partially to a surface of the carriercomprising the container.
 8. The assembly of claim 6 wherein the taggantink is detectable when said device comprising a taggant ink detectableunder ultra-violet light is fractured.
 9. The assembly of claim 5wherein the frangible layer is distorted upon application of shearforces and further comprises a pattern detectable in visible lightcomprised on the frangible layer.
 10. The assembly of claim 9 whereinthe distortion comprises distortion of the pattern detectable undervisible light.
 11. The assembly of claim 5 wherein the label comprises afirst layer that comprises the pattern detectable under visible lightand a second layer comprising the pattern detectable under infra-redlight, and the second layer is comprised on top of the first layer. 12.The assembly of claim 1 wherein the container is a multi-well plate. 13.The assembly of claim 1 wherein one or more of the cover component(s)seals the valuable material in the container.
 14. The assembly of claim1 wherein a valuable material is comprised in the container.
 15. Theassembly of claim 14 wherein the container comprises wells, and thevaluable material is comprised in wells of the container, and one ormore of the wells further comprise one or more taggant inks.
 16. Amethod of detecting the occurrence of tampering with an assemblycontaining a valuable material, comprising a) analyzing the assemblywith a detection system, wherein the assembly comprises: i) a containerfor holding the valuable material and, optionally, a carrier comprisingthe container; ii) one or more cover components that enclose(s) thevaluable material in the container; iii) one or more labels, eachcomprising a plurality of devices that comprise a frangible layer, apattern detectable under visible light, and a pattern detectable underinfra-red light, that reveal tampering by distortion of at least one ofthe plurality of devices, iv) the one or more labels positioned so thatdislodging one or more of the cover components causes the distortion inat least one of the plurality of devices, the distortion detectable by adetection system; and b) detecting the presence or absence of distortionin one or more of the plurality of devices and thereby detecting whethertampering with the assembly has occurred.
 17. The method of claim 16wherein the detection system is an optical detection, system.
 18. Themethod of claim 17 wherein the frangible layer comprises a patterndetectable under visible light, and the distortion comprises adistortion in the pattern detectable under visible light.
 19. The methodof claim 16 wherein the assembly comprises a carrier that contains thecontainer.
 20. The method of claim 17 wherein the distortion comprises afailure to detect the pattern detectable under infra-red light.
 21. Themethod of claim 17 wherein the label further comprises a taggant inkdetectable under ultra-violet light and the distortion comprises thedetection of the taggant ink under ultra-violet light.
 22. The method ofclaim 16 wherein the detection of the distortion is communicated to aremote validator.
 23. The method of claim 22 wherein the remotevalidator is a computer that receives information about the detection ofdistortion in one or more of the plurality of devices, or informationabout the absence of distortion in the plurality of devices.
 24. Themethod of claim 16 wherein the valuable material is a biologicalmaterial.
 25. The method of claim 24 wherein the biological material isDNA.
 26. The method of claim 16 wherein the container comprises one ormore individual compartments, and further comprising the steps ofremoving the one or more cover components and detecting the presence orabsence of one or more taggant inks detectable at a specific wavelengthin one or more of the individual compartments.
 27. A method of,manufacturing a tamper resistant assembly that securely contains avaluable material comprising: a) placing the valuable material in acontainer that is, optionally, comprised by a carrier; b) placing one ormore cover components on the container; c) positioning one or morelabels, each comprising a plurality of devices that comprise a frangiblelayer, a pattern detectable under visible light, and a patterndetectable under infra-red light, that reveal tampering by distortion ofat least one of the plurality of devices, such that dislodging at leastone cover component causes the distortion, the distortion detectable bya detection system.
 28. The method of claim 27 wherein the positioningcomprises affixing the one or more labels partially to a surface of theone or more cover components and partially to a surface of the containeror the optional carrier that comprises the container.
 29. The method ofclaim 27 wherein the detection system is an optical detection system.30. The method of claim 27 wherein the distortion is detectable by aremote validator.
 31. The method of claim 27 wherein the one or morelabels comprises multiple layers, which comprise the plurality ofdevices.
 32. The method of claim 31 wherein the plurality of devicesfurther comprise a taggant ink detectable under ultra-violet light. 33.The method of claim 31 wherein the label further comprises a patterndetectable under visible light comprised on the frangible layer.
 34. Themethod of claim 33 wherein the distortion comprises distortion of thepattern detectable under visible light.
 35. The method of claim 32wherein the taggant ink is detectable when exposed to ultra-violet lightbut is not detectable when the label is intact.
 36. The method of claim35 wherein the label comprises a first layer having the patterndetectable under visible light and further comprises a second layerhaving the pattern detectable under infra-red light and the second layeris comprised on top of the first layer.
 37. The method of claim 27wherein the container is a multi-well plate.
 38. The method of claim 27wherein one or more of the one or more cover components seals thevaluable material in the container.
 39. The method of claim 38 wherein avaluable material is comprised in the container.
 40. The method of claim39 wherein the valuable material comprises a nucleic acid.
 41. Themethod of claim 40 wherein the nucleic acid is fragments of DNA and thefragments are randomly placed in wells of the container.
 42. The methodof claim 27 wherein the container comprises one or more individualcompartments and further comprising the step of placing within the oneor more individual compartments one or more taggant inks detectable at aspecific wavelength.